Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit

FDA UDI

Class II (US FDA UDI)

by Global Life Sciences Solutions USA LLC

Identity

Trade Name: Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit FDA UDI
Generic Name: Anaesthesia breathing circuit, reusable FDA UDI
Device Name: Pediatric 72" Uni-Limb (Coaxial) Circuit with Expiratory Tubing attached @ 3-Way Inspiratory Port, 0.050" ID CO2 Gas Sampling Line, and 1 Liter Non-Latex Breathing Bag. FDA UDI
Model / Reference: VM72PCOAX FDA UDI
Description: Pediatric 72" Uni-Limb (Coaxial) Circuit with Expiratory Tubing attached @ 3-Way Inspiratory Port, 0.050" ID CO2 Gas Sampling Line, and 1 Liter Non-Latex Breathing Bag. FDA UDI

Identifiers

Catalog Number: VM72PCOAX FDA UDI
Primary DI / UDI-DI: 00636207315373 FDA UDI
510(k) Number: K013093 FDA UDI
FDA Product Code: CAH FDA UDI
GMDN Term: Anaesthesia breathing circuit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5260 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 72 Inch FDA UDI

Category: Anaesthesia breathing circuit, reusable

Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit by Global Life Sciences Solutions USA LLC — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Anaesthesia breathing circuit, reusable.

MATRX SCAV, W/SM HOOD(WO/SHUTOF — Parker Hannifin Corp. · Class I
AirTechniques — Baldus Sedation GmbH & Co. KG · Class I
Sil.Plus — Galemed Corp. · Class I
PORTER/BRN ADULT RG ASSY ONLY — Parker Hannifin Corp. · Class I
30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M — Intersurgical Incorporated · Class I
Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
Respiration Tubing — VBM Medizintechnik GmbH · Class I
MATRX SCAV, SHUTOFF VALVE(WO/HO — Parker Hannifin Corp. · Class I

Cleared under the same submission

K013093 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Global Life Sciences Solutions USA LLC

Sources (1)

FDA UDI 01b783c0-454b-4e7c-9a27-ab7b684f063d 37 fields · synced Jun 8, 2026